The Recall Desk
HighFDA (Drugs)·D-0458-2023·Announced 2023-03-22

Alprazolam Tablets Recalled for Potential Cross-Contamination Risk

Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries and no confirmed contamination—only a potential risk from manufacturing deviations. Per the rubric, theoretical hazards without reported harm score at most 3, qualifying this as High severity.

Plain-English summary

Breckenridge Pharmaceuticals, Inc. is recalling Alprazolam Tablets, USP 0.25mg in 100-count, 500-count, and 1,000-count bottles distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility that created a potential risk of cross-contamination.

The product was manufactured by Centaur Pharmaceuticals PVT. LTD. in Pune, India. Multiple lot numbers are affected across all package sizes, with expiration dates ranging from April 2023 through October 2024.

Consumers who have this medication should contact their pharmacist or healthcare provider. Do not discontinue medication without guidance from a healthcare professional. Patients taking affected lots should work with their providers to ensure continuity of care.

The recalled product

Product
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berli
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug
Hazard
  • cross-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #a) 5210734
  • Exp 4/30/2023
  • 5211451
  • Exp 8/31/2024
  • 5220529
  • Exp 4/30/2025
  • b) 5210735
  • 5210736
  • 5210993
  • Exp 5/31/20
  • 5210994
  • Exp 5/31/2023
  • 5211100
  • Exp 6/30/2023
  • 5211452
  • 5211453
  • 5211454
  • 5211640
  • Exp 10/31/2024
  • 5211641

Distribution

Distributed nationwide across the United States.

Related recalls

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